Method of fusing biomaterials with radiofrequency energy

ABSTRACT

A method of fusing biomaterial and tissue using radiofrequency energy includes the steps of: providing a vessel sealing instrument having opposing jaw members which are movable relative to one another to compress tissue therebetween. The vessel sealing instrument includes at least one stop member affixed thereto for regulating the distance between the opposing jaw members. The method also includes the steps of: providing a biomaterial; positioning the biomaterial in abutting relation to tissue; approximating the biomaterial and tissue between the jaw members; compressing the biomaterial and tissue between the jaw members under a working pressure within the range of about 3 kg/cm 2  to about 16 kg/cm 2 ; and energizing the jaw members with radiofrequency energy to effectively fuse the biomaterial and the tissue such that the biomaterial and the tissue reform into a single, fused mass.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. application Ser. No.10/833,989, now U.S. Pat. No. 7,160,299, filed on Apr. 28, 2004, whichclaims the benefit of priority to U.S. Provisional Application Ser. No.60/467,181 filed on May 1, 2003 by Ali Baily, the entire contents ofwhich being incorporated by reference herein.

BACKGROUND

The present disclosure relates to a method of fusing biomaterialutilizing RF energy and, more particularly, the present disclosurerelates to a method of fusing biomaterials to tissue or otherbiomaterials utilizing vessel or tissue sealing technology employing aunique combination of RF energy, pressure and gap distance toeffectively seal or fuse tissue.

TECHNICAL FIELD

During a large majority of operations, surgeons typically utilizesutures, clips and/or some other type of surgical fastener to holdadjacent tissue in opposition to promote tissue healing, graft two (ormore) tissues together and/or perform an anastomosis between two tissuestructures. In certain instances, biodegradable sutures are used, e.g.,collagen “gut” sutures or synthetic polymer sutures, which have theadded benefit of integrating with the body over time or dissolving thuseliminating many adverse reactions to the suture or “foreign body”.

In some instances, additional materials such as biomaterial patches maybe used in conjunction with the sutures and/or staples to provideadditional strength during the initial amalgamation of the tissue and/orduring the pendancy of the tissue repair. For example, polypropylenemesh patches have been used in connection with hernia tissue repair andhernia reconstruction. The patches may also be made from two layers ofsuperimposed collagen, one layer being a porous adhesive layer offibrous collagen sponge and the other layer being a dense collagenand/or gelatin film.

Biological glues utilizing fibrin polymerization have also been used toprovide a nontoxic, flowable material which sets into a solid to jointissue. However, these glues tend to have low adhesive strength and aremore suitable for use as biological sealants which work in conjunctionwith other mechanical securement means, staples, sutures, etc. to jointissue.

Other techniques for tissue repair and tissue anastomosis have also beendeveloped such as laser welding where a laser, e.g., ND:YAG, CO2, etc.,applies light energy to thermally heat the tissue to a point where thetissue proteins denature and the collagenous elements of the tissue forma “biological glue” which adheres the tissue after the tissue areacools. However, the weakness of the weld joint is a primary disadvantageof laser welding, and various filler materials such as collagen must beintroduced to improve the strength of the weld joint.

Elastic fibers have also been proposed for use with laser welding.Elastic fibers are responsible for the elastic properties of severaltissues such as skin, lung and blood vessels, and are partially composedof elastin in a microfibril arrangement. Microfibrils make up theoverall fiber structure and assembly and are responsible for therubber-like elasticity of the fibers. Again, elastin is found in manytissue types, e.g., skin, blood vessels, lung tissue, etc. and impartsstrength and flexibility to those tissues. Elastin may be employed as asupport structure to sustain a section of body tissue such as a vascularstent, a vascular conduit, a ureter replacement, or as a stent orconduit covering, coating or lining. It can also be utilized to providea graft suitable for use in repairing a lumen wall in various tissuereplacement procedures, or for stomach, lung, or heart repair. Elastinmay also be used in colon repair or replacement, for skin repair orreplacement, and/or as a cosmetic implantation or breast implant.

U.S. Pat. Nos. 5,989,244, 5,990,379, 6,087,552, 6,110,212 and 6,372,228,discuss the utilization of elastin and elastin-based materials to repairtissue structures, support body tissue and/or graft tissue structures bylaser welding. More particularly, the techniques described in thesepatents disclose the utilization of laser energy in combination withphotosensitizing or energy absorbing dyes, e.g., indocyanine green dye,to thermally bond elastin-based materials to a tissue sight. The energyabsorbing dye is applied to the tissue site and/or the elastin material.Because the dye has an absorption peak at a wavelength corresponding tothe wavelength emitted by the laser, the tissue and the elastin-basedmaterial absorb much less light at the same wavelength and the energyand resulting thermal effects are generally confined to a predefinedzone around the dye. Ideally, the absorbance of the dye layer ispreviously or concurrently determined so that the optimal amount oflight for optimal bonding can be delivered.

As mentioned in these aforementioned patents, laser welding is a processwhose success is dependent upon the proper management and control ofmany key properties which ultimately effect the overall success offusing elastin-based materials and tissue substrates. Some of these keyproperties include: the magnitude of the wavelength, energy level,absorption rate, and light intensity during irradiation and theconcentration of the energy absorbing material.

Unfortunately, laser welding is a relatively complex process whichrelies heavily on the use of energy-absorbing dyes with varyingwavelengths and large and expensive laser units to thermally fuse theelastin-based materials and the tissue substrates. It would therefore bedesirable to provide a simpler and less expensive method and process forfusing biomaterials to tissue substrates or other biomaterials withoutrelying on energy absorbing dyes or expensive laser units.

Vessel sealing or tissue sealing is a recently-developed technologywhich utilizes a unique combination of radiofrequency energy, pressureand gap control to effectively seal or fuse tissue between two opposingjaw members or sealing plates. Vessel or tissue sealing is more than“cauterization” which is defined as the use of heat to destroy tissue(also called “diathermy” or “electrodiathermy”) and vessel sealing ismore than “coagulation” which is defined as a process of desiccatingtissue wherein the tissue cells are ruptured and dried. “Vessel sealing”is defined as the process of liquefying the collagen, elastin and groundsubstances in the tissue so that it reforms into a fused mass withsignificantly-reduced demarcation between the opposing tissuestructures.

In order to effectively “seal” tissue or vessels, two predominantmechanical parameters must be accurately controlled: 1) the pressureapplied to the vessel or tissue; and 2) the gap distance between theconductive tissue contacting surfaces (electrodes). As can beappreciated, both of these parameters are affected by the thickness ofthe tissue being sealed. Accurate application of pressure is importantfor several reasons: to reduce the tissue impedance to a low enoughvalue that allows enough electrosurgical energy through the tissue; toovercome the forces of expansion during tissue heating; and tocontribute to the end tissue thickness which is an indication of a goodseal. It has been determined that a good seal for certain tissues isoptimum between 0.001 inches and 0.006 inches. For other tissues andbiomaterials, other ranges may apply for optimum sealing. In anyinstance it is important to determine seal ranges for particular tissuetypes since below certain ranges, seals may shred or tear and abovecertain ranges the tissue may not be properly or effectively sealed.

With respect to smaller vessels or tissue, the pressure applied becomesless relevant and the gap distance between the electrically conductivesurfaces becomes more significant for effective sealing. In other words,the chances of the two electrically conductive surfaces touching duringactivation increases as the tissue thickness and the vessels becomesmaller.

Thus, a need exists to develop a relatively simple and inexpensivemethod of fusing elastin or elastin-based biomaterials to tissuesubstrates and/or other elastin-based biomaterials utilizing thebenefits of vessel sealing technology and without utilizing energyabsorbing dyes or large expensive laser units.

SUMMARY

The present disclosure relates to a method of fusing biomaterial andtissue using radiofrequency energy and includes the steps of: providinga vessel sealing instrument having opposing jaw members which aremovable relative to one another to compress tissue therebetween. Thevessel sealing instrument includes at least one stop member affixedthereto for regulating the distance between opposing jaw members.Preferably, the stop member(s) project from an electrically conductivesealing surface of each opposing jaw member to regulate the distance towithin a range of about 0.004 inches to about 0.010 inches.

The method also includes the steps of: providing a biomaterial (e.g.,elastin biomaterial, collagen-based biomaterials, elastin-basedbiomaterials and fibrin-based biomaterials); positioning the biomaterialin abutting relation to tissue; approximating the biomaterial and tissuebetween the jaw members; compressing the biomaterial and tissue betweenthe jaw members under a working pressure preferably within the range ofabout 3 kg/cm² to about 16 kg/cm²; and energizing the jaw members withradiofrequency energy to effectively fuse the biomaterial and the tissuesuch that the biomaterial and the tissue reform into a single, fusedmass. The method may also include the steps of: extracting collagen fromthe biomaterial; and confirming the absence of collagen from thebiomaterial.

Preferably, the stop member(s) of the providing step regulates thedistance between opposing jaw members within the range of about 0.004inches to about 0.010 inches for larger tissue structure with elastinand about 0.001 inches to about 0.006 inches for smaller tissuestructures with elastin. In one embodiment, the biomaterial is shaped,e.g., tubular, for performing an anastomosis. In other embodiments, thebiomaterial is shaped in a patch for tissue repair or tissuereplacement.

Another method of fusing biomaterial and tissue using radiofrequencyenergy according to the present disclosure includes the steps of:providing a circular stapling instrument having a stapler support memberwhich supports an array of staples and an opposing anvil. The supportmember is movable relative to the anvil to compress tissue therebetween.Preferably, the stapler support member and the anvil includeelectrically conductive sealing surfaces.

The method also includes the steps of: everting an end of a segment ofbiomaterial; positioning the everted end of the biomaterial in abuttingrelation to an everted tissue end such that the respective intimae ofthe everted biomaterial and the tissue oppose one another; compressingthe biomaterial and tissue between the stapler support member and theanvil under a working pressure within the range of about 3 kg/cm² toabout 16 kg/cm² (and, preferably within the working range of about 4.5kg/cm² to about 8.5 kg/cm²) between energizing the support member andthe anvil with radiofrequency energy to effectively fuse the biomaterialand the tissue such that the tissue and the biomaterial reform into asingle, fused mass; and actuating the circular stapling instrument tofire the staples through the biomaterial and tissue and against theanvil.

Yet another method of fusing biomaterial and tissue using radiofrequencyenergy according to the present disclosure includes the steps of:providing a circular stapling instrument similar to the one describedabove and providing a biomaterial. The method also includes the stepsof: everting the ends of two tissue segments to expose tissue intimae;positioning at least one segment of biomaterial between the everted endsof the two tissue segments; compressing the two tissue segments and thebiomaterial between the stapler support member and the anvil under aworking pressure; energizing the support member and the anvil withradiofrequency energy to effectively fuse the biomaterial and the twotissue segments such that the two tissue segments and the biomaterialreform into a single, fused mass; and actuating the circular staplinginstrument to deform the staple through the biomaterial and tissue andagainst the anvil.

BRIEF DESCRIPTION OF THE DRAWINGS

The file of this patent contains at least one drawing executed in color.Copies of this patent with color drawing(s) will be provided by thePatent and Trademark Office upon request and payment of the necessaryfee.

Various embodiments of the subject methods and component partsassociated therewith are described herein with reference to the drawingswherein:

FIG. 1A is a perspective view of an elastin biomaterial according to thepresent disclosure which can be used with a radiofrequency vesselsealing instrument to repair, heal and/or replace tissue;

FIG. 1B is an enlarged microscopic view of a normal aorta showing bothcollagen and elastin fibers;

FIG. 1C is an enlarged, microscopic view (shown at 40× magnification) ofan aorta which has been treated using a sodium hydroxide (NaOH)extraction process (“NaOH/Boiled”);

FIG. 1D is an enlarged, unfiltered microscopic view (shown at 10×magnification) of the unsealed NaOH/Boiled aorta of FIG. 1C;

FIG. 1E is an enlarged, filtered microscopic view (shown at 10×magnification with a birefringence filter) of the unsealed NaOH/Boiledaorta of FIG. 1C confirming the absence of collagen from thebiomaterial;

FIG. 2A is an enlarged, microscopic view (shown at 40× magnification) ofthe unsealed NaOH/Boiled aorta of FIG. 1C;

FIG. 2B is an enlarged, microscopic view (shown at 40× magnification) of2 pieces of NaOH/Boiled aorta of FIG. 2A, after being sealed utilizingRF vessel sealing technology;

FIG. 2C is an enlarged, microscopic view (shown at 2× magnification) ofFIG. 2B showing two layers of elastin biomaterial sealed togetherutilizing RF vessel sealing technology;

FIGS. 2D and 2E are enlarged, microscopic views of the sealing areabetween the two layers of elastin biomaterial of FIG. 2C under varyingmagnifications;

FIG. 3A is a side, perspective view of an endoscopic vessel sealingforceps for use with fusing elastin biomaterials according to thepresently disclosed method;

FIG. 3B is a side, cross section of the forceps of FIG. 3A;

FIG. 3C is an enlarged, side, perspective view of an end effector of theforceps of FIG. 3A;

FIG. 3D is an enlarged, side view of the end effector of FIG. 3C;

FIG. 4A is a side, perspective view of an open vessel sealing forcepsfor use with fusing elastin biomaterials according to the presentlydisclosed method;

FIG. 4B is an enlarged, side, perspective view of an end effector of theforceps of FIG. 4A shown in an open configuration;

FIG. 4C is an enlarged, side, perspective view of the end effector ofthe forceps of FIG. 4A shown in a closed configuration;

FIG. 5A is an enlarged, side, perspective view of the forceps of FIG. 4Ashown approximating tissue and biomaterial between two opposing jawmembers;

FIG. 5B is a side, perspective view of the forceps of FIG. 4A shown withtissue and biomaterial grasped between opposing jaw members and a gapdistance being maintained between opposing jaw surfaces;

FIG. 5C is an enlarged, side, perspective view of an alternate electrodeassembly for use with sealing biomaterials;

FIGS. 5D and 5E are schematic representations of the electrode assemblyof FIG. 5C.

FIGS. 6A and 6B are schematic representations of two gasket-shapedbiomaterials being fused between two opposing jaw members to perform anend-to-end anastomosis;

FIGS. 7A and 7B are schematic representations of one gasket-shapedbiomaterial being fused between everted tissue ends by two jaw membersto perform an end-to-end anastomosis;

FIG. 8 is a schematic representation of one gasket-shaped biomaterialbeing fused between everted tissue ends to enhance an end-to-endanastomosis with an anastomotic stapler;

FIGS. 9A and 9B are schematic representations of a biomaterial andtissue being directly fused between two opposing jaw members to performan end-to-end anastomosis; and

FIG. 10 is a schematic representation of a biomaterial being fuseddirectly with everted tissue to enhance an end-to-end anastomosis withan anastomotic stapler.

DETAILED DESCRIPTION

The present invention relates to biomaterials and to methods of fusingbiomaterials to tissue (or other biomaterials) using so-called “vesselsealing” technology which involves a unique combination ofradiofrequency (RF) energy, specified pressures and specific gapdistances between opposing electrically conductive surfaces toeffectively and consistently melt the tissue and/or biomaterial into afused mass with limited demarcation. For the purposes herein, the term“biomaterials” includes collagen-based materials, elastin-basedmaterials and fibrin-based materials and elastin. The biomaterials maybe natural, synthetic and/or engineered biomaterials depending upon aparticular purpose.

It is envisioned that the biomaterials may be sealed or fused to tissuesubstrates, soft tissue (lung, intestine, bowel, blood vessels, muscles,skin, etc.) or other biomaterials utilizing vessel sealing technology asa means for tissue healing, reconstruction, repair and/or replacement.

For the purposes herein, an elastin biomaterial will be discussed,however, it is envisioned that other biomaterials may also be utilizedin a similar fashion to accomplish the same or similar purposes asdescribed herein. For example, there are many types of collagenbiomaterial sheets, collagenous bioartificial blood vessels, andcollagen grafts. Various methods exist for the manufacture of differentbiomaterials. Moreover, collagen can come from naturally occurringtissues such as dura matter or pericardium, or the collagen may bereconstituted into collagen sheets made from either bovine intestines,bovine skin, or Achilles tendon which are bathed in or combined withproteolytic enzymes, acids, alkalis, and/or ethylene oxides. Spidroin,the elastin-like protein in spider webs, may also be used as abiomaterial for the purposes herein.

Elastin biomaterials are advantageous in certain types of tissue repair.Many known techniques are available for preparing elastin biomaterialssuch as those techniques described in U.S. Pat. Nos. 4,132,746,4,500,700, 4,187,852, 4,589,882, 4,693,718, 4,783,523, 4,870,055,5,064,430, 5,336,256 5,989,244, 5,990,379, 6,087,552, 6,110,212 and6,372,228, the entire contents of all of which are hereby incorporatedby reference herein.

For the purposes herein, one method of elastin lamina extraction isgenerally outlined below and is described by H. Shangguam et al. in thearticle entitled: “Pressure Effects on Soft Tissues Monitored by Changesin Tissue Optical Properties”, Laser-Tissue Interaction IX, S. L.Jacques Ed., Proc. SPIE 3254, 366-371 (1998). To change a normal aortainto elastin lamina “biomaterial”, the following steps may be taken:

-   -   Aortas are placed into 60° C. 0.5 M NaOH for 1-1.5 hours to        digest collagen and all tissue constituents except the elastin        lamina;    -   The remaining elastin lamina is put into room-temperature        deionized water for 30 minutes.    -   The remaining elastin lamina is put into boiling deionized water        for 30 minutes to remove NaOH and sterilize the biomaterial; and    -   The elastin biomaterial is kept in the saline and refrigerated.

To confirm the absence of collagen within the elastin biomaterial,special histological stains that target certain receptors on thecollagen may be employed. Birefringence can also be used to check forcollagen presence (collagen has a gold hue under birefringence light).

Any method of extracting/removing cellular material, proteins and fatsfrom the tissue while leaving the extracellular elastin matrix intactcan be used. For example, the methods can involve combinations ofacidic, basic, detergent, enzymatic, thermal or erosive means, as wellas the use of organic solvents. Alternatively, the tissue may beincubated or bathed in various solutions including: formic acid,trypsin, guanidine, ethanol, diethylether, acetone, t-butanol, andsonication. As can be appreciated, the incubation temperature andincubation time will vary depending on the starting material andextracting solution utilized. As explained in more detail below, theresulting elastin biomaterial may be molded so as to render it asuitable size and shape for any many different purposes. It isenvisioned that fusing various biomaterials (e.g., collagen-to-elastin,collagen-to-tissue, elastin-to-elastin, elastin-to-tissue orcollagen-to-collagen) will yield unique bonding characteristics(strength of seal, seal thickness, seal quality, seal consistency,etc.).

FIGS. 1A and 1C show a schematic representation of a piece of elastinbiomaterial (NaOH/Boiled aorta) 10′ which has been prepared according tothe above extraction process. The collagen 14 fibers have beeneliminated from the material such that only elastin 12 remains. FIGS. 1Band 1C show before and after microscopic views (under a 40×magnification) of a normal aorta 10 prepared according to theabove-identified extraction process. More particularly, FIG. 1B depictsa normal aorta 10 with both collagen 14 and elastin fibers 12 clearlyevident. It is important to note the various histological stains whichhelp distinguish the various fibers. Verhoeff's Van Geistan histologicalstain stains elastin fibers black (See FIG. 1C). Hematoxylin and Eosin(H&E) histological stain stains tissue pink (See FIG. 1B).

FIG. 1C shows the aorta 10′ after being bathed in a 60° C. sodiumhydroxide solution for approximately 1 to 1.5 hours to extract thecollagen 14. FIG. 1D shows the aorta 10′ at 10× magnification withoutthe use of a birefringence filter. FIG. 1E shows the same aorta 10′ atthe same magnification under a birefringence filter, confirming theabsence of the collagen fibers as a result of the extraction process(under a birefringence filter, collagen would birefringe in a gold-ishhue).

As can be appreciated, sheets or patches of elastin biomaterial 10′ maybe selectively varied in size, thickness and shape and/or may be formedinto molds and scaffolding depending upon the intended purpose for thebiomaterial. Specifically, the tubular nature of the normal aorta may bemaintained if desired. Elastin biomaterial 10′ may also be molded intotubular segments by injecting the elastin into tubular molds. Tubularsegments may be made in virtually any size or length and the inner andouter tube diameter may vary according to a particular purpose. Forexample, a small tube may be used for a coronary arterial stent and alarge tube of 1-5 inches in diameter may be used as an annularly weldedpatch for anastomosis of the small intestine or colon.

The prepared elastin biomaterial 10′ may be used to repair portions ofdiseased or damaged vascular tissue, nonvascular tissue (e.g.,esophagus, paracardium, lung, etc.) or as a skin layer replacement foruse in burn or wound treatments. Internal wound repair is also is alsoan application. For instance, the elastin biomaterial 10′ may also beused in organ reconstruction, e.g., molded in a pouch-like configurationfor bladder reconstruction or shaped for esophageal replacement.

It may be desirable to use the elastin biomaterial 10′ in combinationwith a supporting material having strong mechanical properties. Forthose applications, the elastin biomaterial 10′ can be coated on thesupporting material using various molding techniques described herein.Suitable supporting materials include polymers, such as wovenpolyethylene terepthalate (Dacron), teflon, polyolefin copolymer,polyurethane polyvinyl alcohol or other polymer. In addition, a polymerthat is a hybrid between a natural polymer, such as fibrin and elastin,and a non-natural polymer such as a polyurethane, polyacrylic acid orpolyvinyl alcohol may be used. Other prostheses that can be made fromsynthetics (or metals) and coated with the elastin biomaterial 10′ (orfrom the biomaterial/synthetic hybrids) include cardiac valve rings andesophageal stents.

Once the elastin biomaterial 10′ is prepared and formed into the desiredshape, thickness and consistency it can be fused to tissue (or tissuesubstrates or other elastin biomaterial 10′) utilizing vessel sealingtechnology. FIGS. 2A-2E show a resulting seal 20 between two elastinbiomaterials 10 a and 10 b at various levels of magnification. Moreparticularly, FIG. 2A shows the unsealed, boiled elastin 10 at 40×magnification prior to sealing. FIG. 2B shows two elastin biomateriallayers 10 a and 10 b at 40× magnification after sealing, illustrating aresulting seal 20 a,b between these two elastin layers 10 a and 10 b. Acomparison of FIGS. 2A and 2B shows a significant change in the elastinbiomaterials 10 a, 10 b as a result of the sealing process. Moreparticularly, the black elastin fibers have become condensed (i.e.,fused) and individual fiber strands have become unrecognizable.

FIGS. 2C-2E show close-up views of the same seal 20 a,b at 2×magnification, 10× magnification and 40× magnification, respectively.The midline of the seal, i.e., where the two layers 10 a and 10 b ofbiomaterial come together, can be seen running diagonally in the lowerright close-up of FIG. 2E.

It is envisioned that the elastin biomaterials 10′ described herein maybe fused to other tissues or other biomaterials. As mentioned above,vessel sealing utilizes a unique combination of controlled RF energy,pressure (within a specified pressure range) and specific gap distancesbetween opposing tissue contacting surfaces to melt the elastinbiomaterial 10′ and tissue into a single mass (See FIG. 2B). Theseparameters must be carefully controlled to assure consistent andeffective sealing/fusion of the elastin biomaterial 10′. Briefdescriptions of various types of sealing instruments (i.e., open forcepsand endoscopic forceps) which may be utilized to effectively sealelastin biomaterial 10′ are included below with reference to FIGS.3A-5E. More detailed descriptions of various vessel sealing instrumentsand various methods for sealing tissue are described in commonly-ownedU.S. patent application Ser. No. 10/369,894 entitled “VESSEL SEALER ANDDIVIDER AND METHOD MANUFACTURING SAME”, U.S. patent application Ser. No.10/460,926 entitled “VESSEL SEALER AND DIVIDER FOR USE WITH SMALLTROCARS AND CANNULAS”, U.S. patent application Ser. No. 10/284,562entitled “VESSEL SEALING INSTRUMENT” and U.S. patent application Ser.No. 10/284,562 entitled “BIPOLAR CONCENTRIC ELECTRODE ASSEMBLY FOR SOFTTISSUE FUSION” which are all incorporated by reference herein in theirentirety.

FIG. 3A shows one example of an endoscopic vessel sealing instrumentwhich may be employed for fusing the elastin biomaterials 10′. For thepurposes herein, either an endoscopic instrument or an open instrumentmay be utilized for fusing elastin biomaterials. Obviously, differentelectrical and mechanical connections and considerations apply to eachparticular type of instrument and biomaterial, however, the novelaspects with respect to the electrode sealing assembly and its operatingcharacteristics remain generally consistent with respect to both theopen or endoscopic designs.

More particularly, FIG. 3A shows a sealing forceps 200 which generallyincludes a housing 220, a handle assembly 230, a rotating assembly 280,a trigger assembly 270 and an end effector assembly 400 which mutuallycooperate to grasp, seal and, if warranted, divide tissue. The forceps200 includes a shaft 212 which has a distal end 214 dimensioned tomechanically engage the end effector assembly 400 and a proximal end 216which mechanically engages the housing 220. The proximal end 216 ofshaft 212 is dimensioned to mechanically engage the rotating assembly280.

Forceps 200 also includes a plug 300 which connects the forceps 200 to asource of electrosurgical energy, e.g., an electrosurgical generator(not shown) via an electrical cable 310. Handle assembly 230 includes afixed handle 250 and a movable handle 240. Handle 240 moves relative tofixed handle 250 to actuate the end effector assembly 400 and enable auser to grasp and manipulate the elastin biomaterial 10′. Moreparticularly, the end effector assembly 400 includes a pair of opposingjaw members 410 and 420 which move in response to movement of handle 240from an open position wherein the jaw members 410 and 420 are disposedin spaced relation relative to one another, to a clamping or closedposition wherein the jaw members 410 and 420 cooperate to grasp elastinbiomaterial 10′ and tissue substrate 900 therebetween (See FIG. 5B).

As best shown in FIG. 3B, the housing 220 encloses a drive assembly 221which cooperates with the movable handle 240 to impart movement of thejaw members 410 and 420 from the open position to the clamping or closedposition. The handle assembly 230 can generally be characterized as afour-bar mechanical linkage composed of the following elements: movablehandle 240, a link 265, a cam-like link 236 and a base link embodied byfixed handle 250 and a pair of pivot points 267 and 269. Movement of thehandle 240 activates the four-bar linkage which, in turn, actuates thedrive assembly 221 for imparting movement of the opposing jaw members410 and 420 relative to one another to grasp elastin biomaterial 10′therebetween.

As best shown in FIGS. 3C and 3D, each jaw member 410, 420 includes ajaw housing 416, 426, an insulative substrate or insulator 414, 424 andan electrically conducive surface 412, 422. Insulators 414, 424 may besecurely engaged to the electrically conductive sealing surface bystamping, overmolding, overmolding a stamped electrically conductivesealing plate and/or overmolding a metal injection molded seal plate.All of these manufacturing techniques produce electrodes having anelectrically conductive surfaces 412, 422 which are substantiallysurrounded by insulating substrates 414, 424. Each insulator's 414, 424electrically conductive sealing surface 412, 422 and the outer,non-conductive jaw housing 416, 426 are dimensioned to limit and/orreduce many of the known undesirable effects related to sealing, e.g.,flashover, thermal spread and stray current dissipation. The jaw members410 and 420 are electrically isolated from one another such thatelectrosurgical energy can be effectively transferred to electricallyconductive surfaces 412 and 422 and through the elastin biomaterial 10′to form a seal.

As the handle 240 is squeezed, the cam link 236, through the mechanicaladvantage of the four-bar mechanical linkage, is rotated generallyproximally about pivots 237 and 269 such that the cam piston 238 biasestab 225 to compress spring 222 against flange 223. Simultaneously, driverod 232 is pulled proximally which, in turn, causes cam pin 470 (SeeFIGS. 3C and 3D) to move proximally and close the jaw members 410 and420 relative to one another. The jaw members 410 and 420 may be opened,closed and rotated to manipulate the elastin biomaterial 10′ untilsealing is desired. This enables the user to position and re-positionthe forceps 200 prior to activation and sealing.

A series of stop members 150 a, 150 b and 150 c is preferably disposedon the inner facing surfaces of the electrically conductive sealingsurfaces 412 and 422 to facilitate gripping and manipulation of theelastin biomaterial 10′ and to define a gap “G” (See FIG. 5B) betweenopposing jaw members 410 and 420 during sealing. As best seen in FIGS.3C and 3D, in order to achieve a desired spacing between theelectrically conductive surfaces 412 and 422 of the respective jawmembers 410, 420, (i.e., gap distance) and apply a desired force to sealthe tissue to the biomaterial, at least one jaw member 410 and/or 420includes stop member(s), e.g., 150 a, 150 b and 150 c which limit themovement of the two opposing jaw members 410 and 420 relative to oneanother. The stop member(s), e.g., 150 a, extends from the sealingsurface or tissue contacting surface 422 a predetermined distanceaccording to the specific material properties of the stop members 150 a(e.g., compressive strength, thermal expansion, etc.) to yield aconsistent and accurate gap distance during sealing. The gap distancebetween opposing sealing surfaces 412, 422 during sealing ofbiomaterials preferably ranges from about 0.004 inches to about 0.010inches.

Stop members 150 a-150 c are preferably made from an insulativematerial, e.g., parylene, nylon and/or ceramic, and are dimensioned tolimit opposing movement of the jaw members 410 and 420 to within theabove-mentioned gap range. The stop members 150 a-150 c can be disposedon one or both of the jaw members 410 and 420 and may be dimensioned ina variety of different shapes and sizes, longitudinal, circular,ridge-like, etc.

The non-conductive stop members 150 a-150 c are molded onto the jawmembers 410 and 420 (e.g., overmolding, injection molding, etc.),stamped onto the jaw members 410 and 420, deposited (e.g., deposition)onto the jaw members 410 and 420 and/or thermally sprayed onto thesurface of the jaw members 410 and 420 (e.g., a ceramic material may bethermally sprayed) to form the stop members 150 a-150 c. Many differentconfigurations for the stop members 150 a-150 c are discussed in detailin commonly-assigned, co-pending U.S. Application Ser. No.PCT/US01/11413 entitled “VESSEL SEALER AND DIVIDER WITH NON-CONDUCTIVESTOP MEMBERS” by Dycus et al. which is hereby incorporated by referencein its entirety herein.

Once the desired position for the sealing site is determined and the jawmembers 410 and 420 are properly positioned, handle 240 may becompressed fully to lock the jaw members 410 and 420 in a closedposition against the elastin biomaterial 10′ and tissue substrate/otherbiomaterial. The details for locking the handle 240 with respect tohandle 250 are disclosed in commonly-owned U.S. patent application Ser.No. 10/369,894 entitled “VESSEL SEALER AND DIVIDER AND METHODMANUFACTURING SAME” which is incorporated in its entirety by referenceherein. When the jaw members 410 and 420 are fully compressed about theelastin biomaterial 10′ and tissue substrate (or other biomaterial) theforceps 200 is now ready for selective application of RF energy.

Experimental results suggest that the magnitude of pressure exerted onthe elastin biomaterial 10′ by the seal surfaces 412 and 422 isimportant in assuring a proper surgical seal. Pressures within a workingrange of about 3 kg/cm² to about 16 kg/cm² and, preferably, within aworking range of 4.5 kg/cm² to 8.5 kg/cm² have been shown to beeffective for sealing various tissue types. In addition to keeping thepressure within a working range (i.e., about 3 kg/cm² to about 16kg/cm²) and the gap distance within a specified range (i.e., about 0.004inches to about 0.010 inches) the electrical power should be kept withinthe range of about 1 W to about 350 W, about 1 Vrms to about 400 Vrmsand about 0 Amps to about 5.5 Amps. Moreover, the electrodes and/or thesealing surfaces 412 and 422 should be designed for low thermal mass tooptimize thermal heating between jaw members 410 and 420 and minimizethermal loss through the device.

Preferably, the four-bar handle assembly 230, spring 222 and driveassembly 221 are manufactured and dimensioned such that the cooperationof these working elements, i.e., the four-bar handle assembly 230 (andthe internal working components thereof, the spring 222 and driveassembly 221, maintain tissue pressures within the above working ranges.Alternatively, the handle assembly 230, the spring 222 or the driveassembly 221 may be manufactured and dimensioned to produce pressureswithin the above working range independently of the dimensions andcharacteristic of the other of these working elements. One such handleassembly is described in commonly-owned U.S. patent application Ser. No.10/369,894 entitled “VESSEL SEALER AND DIVIDER AND METHOD MANUFACTURINGSAME”

By controlling the intensity, frequency and duration of the RF energyapplied to the elastin biomaterial 10′, the user can selectively sealthe elastin biomaterial 10′ as needed for a particular purpose. As canbe appreciated, various biomaterials and the physical characteristicsassociated with each biomaterial and the particular purpose of thebiomaterial may require unique sealing electrical parameters. It isenvisioned that the above forceps 200 may be utilized in connection witha closed-loop RF control system which optimizes sealing based uponpre-surgical conditions or changes in physical or electrical conditionsduring sealing. One example of a closed-loop control system is describedin commonly-owned and concurrently-filed U.S. patent application Ser.No. 10/427,832 entitled “METHOD AND SYSTEM FOR CONTROLLING OUTPUT OF RFMEDICAL GENERATOR” and commonly-owned and concurrently-filed U.S. PatentApplication Ser. No. [filed as U.S. Provisional Application Ser. No.60/466,954] entitled “METHOD AND SYSTEM FOR PROGRAMMING AND CONTROLLINGAN ELECTROSURGICAL GENERATOR SYSTEM” which are both incorporated intheir entirety by reference herein. In general, the closed-loop control,system includes a user interface for allowing a user to select at leastone pre-surgical parameter, such as the type of surgical instrumentoperatively connected to the generator, the type of tissue and/or adesired surgical effect. A sensor module is also included forcontinually sensing at least one of electrical and physical propertiesproximate the surgical site and generating at least one signal relatingthereto.

The closed loop control system also includes a control module forcontinually receiving or monitoring surgical parameters and each of thesignals from the sensor module and processing each of the signals inaccordance with a desired surgical effect using a microprocessor,computer algorithm and/or a look-up table. The control module generatesat least one corresponding control signal relating to each signal fromthe sensor module, and relays the control signal to the electrosurgicalgenerator for controlling the generator. The closed loop system may beemployed in a feedback circuit or part of a surgical method foroptimizing a surgical seal. The method includes the steps of: applying aseries of electrical pulses to the surgical site; continually sensingelectrical and physical properties proximate the surgical site; andvarying pulse parameters of the individual pulses of the series ofpulses in accordance with the continually-sensed properties.

As mentioned above, it is also contemplated that the sealing surfaces412 and 422 of the jaw members 410 and 420 can be made from or coatedwith non-stick materials. When utilized on the sealing surfaces 412 and422, these materials provide an optimal surface energy for eliminatingsticking due in part to surface texture and susceptibility to surfacebreakdown due to electrical effects and corrosion in the presence ofbiologic tissues. It is envisioned that these materials exhibit superiornon-stick qualities over stainless steel and should be utilized on theforceps 200 in areas where the exposure to pressure and RF energy cancreate localized “hot spots” more susceptible to tissue adhesion. As canbe appreciated, reducing the amount that biomaterials 10′ “stick” duringsealing improves the overall efficacy of the instrument. The non-stickmaterials may be manufactured from one (or a combination of one or more)of the following “non-stick” materials: nickel-chrome, chromium nitride,MedCoat 2000, Inconel 600 and tin-nickel.

For example, high nickel chrome alloys, Ni200, Ni201 (˜100% Ni) may bemade into electrodes or sealing surfaces by metal injection molding,stamping, machining or any like process. Also and as mentioned above,the sealing surfaces 412 and 422 may also be “coated” with one or moreof the above materials to achieve the same result, i.e., a “non-sticksurface”. One particular class of materials disclosed herein hasdemonstrated superior non-stick properties and, in some instances,superior seal quality. For example, nitride coatings which include, butnot are not limited to: TiN, ZrN, TiAIN, and CrN are preferred materialsused for non-stick purposes. CrN has been found to be particularlyuseful for non-stick purposes due to its overall surface properties andoptimal performance. Other classes of materials have also been found toreduce overall sticking. For example, high nickel/chrome alloys with aNi/Cr ratio of approximately 5:1 have been found to significantly reducesticking in bipolar instrumentation. One particularly useful non-stickmaterial in this class is Inconel 600. Bipolar instrumentation havingsealing surfaces 412 and 422 made from or coated with Ni200, Ni201(˜100% Ni) also showed improved non-stick performance over typicalbipolar stainless steel electrodes.

An open forceps 500 is also contemplated for use in connection withtraditional open surgical procedures and is shown by way of example inFIG. 4A. Open forceps 500 includes a pair of elongated shaft portions512 a, 512 b each having a proximal end 516 a and 516 b, respectively,and a distal end 514 a and 514 b, respectively. The forceps 500 includesjaw assembly 600 which attaches to the distal ends 514 a and 514 b ofshafts 512 a and 512 b, respectively. Jaw assembly 600 includes opposingjaw members 610 and 620 which are pivotably connected about a pivot pin650 (See FIGS. 4B and 4C).

Preferably, each shaft 512 a and 512 b includes a handle 517 a and 517 bdisposed at the proximal end 516 a and 516 b thereof which each define afinger hole 518 a and 518 b, respectively, therethrough for receiving afinger of the user. As can be appreciated, finger holes 518 a and 518 bfacilitate movement of the shafts 512 a and 512 b relative to oneanother which, in turn, pivot the jaw members 610 and 620 from an openposition wherein the jaw members 610 and 620 are disposed in spacedrelation relative to one another for manipulating tissue to a clampingor closed position wherein the jaw members 610 and 620 cooperate tograsp elastin biomaterial 10′ and tissue substrate therebetween. Aratchet 530 is preferably included for selectively locking the jawmembers 610 and 620 relative to one another at various positions duringpivoting.

Preferably, each position associated with the cooperating ratchetinterfaces 530 holds a specific, i.e., constant, strain energy in theshaft members 512 a and 512 b which, in turn, transmits a specificclosing force to the jaw members 610 and 620. It is envisioned that theratchet 530 may include graduations or other visual markings whichenable the user to easily and quickly ascertain and control the amountof closure force desired between the jaw members 610 and 620. One of theshafts, e.g., 512 b, includes a proximal shaft connector/flange 519which is designed to connect the forceps 500 to a source of RF energy(not shown) via an electrosurgical cable 310 and plug 300.

As best seen in FIGS. 4B and 4C, the two opposing jaw members 610 and620 are generally symmetrical and include similar component featureswhich cooperate to permit facile rotation about pivot pin 650 to effectthe grasping and sealing of elastin biomaterial 10′ and tissue substrate900 (See FIG. 5B). Jaw member 610 includes an insulated outer housing614 which is dimensioned to mechanically engage an electricallyconductive sealing surface 612. Preferably, outer insulative housing 614extends along the entire length of jaw member 610 to reduce alternate orstray current paths during sealing and/or incidental burning of elastinbiomaterial 10′ or the underlying tissue substrate. Likewise, jaw member620 includes similar elements which include an outer housing 624 whichengages an electrically conductive sealing surface 622 and anelectrically conductive sealing surface 622.

Much like the afore described endoscopic forceps of FIGS. 3A-3C, the jawmembers 610 and 620 of the open forceps 500 also include at least onestop member 150 a disposed on the inner facing surface of theelectrically conductive sealing surface 612 (and/or 622). Alternativelyor in addition, the stop member 150 a may be positioned adjacent to theelectrically conductive sealing surfaces 612, 622 or proximate the pivotpin 650. The stop member(s) is preferably designed to define a gap “G”(See FIG. 5B) between opposing jaw members 610 and 620 during this typeof sealing. Preferably the separation distance during sealing or the gapdistance “G” is within the range of about 0.004 inches (˜0.1016millimeters) to about 0.010 inches (˜0.254 millimeters).

As mentioned above, two mechanical factors play an important role indetermining the resulting thickness of the sealed elastin biomaterial10′ and effectiveness of the seal, i.e., the pressure applied betweenopposing jaw members 610 and 620 and the gap “G” between the opposingjaw members 610 and 620 during the sealing process. Applying the correctforce is also important for other reasons: to reduce the impedance ofthe elastin biomaterial 10′ (and/or elastin biomaterial 10′ and tissuesubstrate) to a low enough value that allows enough current through theelastin biomaterial 10′; and to overcome the forces of expansion duringthe heating of the elastin biomaterial 10′ in addition to contributingtowards creating the required seal thickness necessary for asatisfactory seal.

Insulated outer housing 614 is dimensioned to securely engage theelectrically conductive sealing surface 612. It is envisioned that thismay be accomplished by stamping, by overmolding, by overmolding astamped electrically conductive sealing plate and/or by overmolding ametal injection molded seal plate. All of these manufacturing techniquesproduce an electrode having an electrically conductive surface 612 whichis substantially surrounded by an insulated outer housing 614. Theinsulated outer housing 614 and the electrically conductive sealingsurface 612 are preferably dimensioned to limit and/or reduce many ofthe known undesirable effects related to sealing, e.g., flashover,thermal spread and stray current dissipation. These and other envisionedembodiments are discussed in commonly-assigned Application Ser. No.PCT/US01/11412 entitled “ELECTROSURGICAL INSTRUMENT WHICH REDUCESCOLLATERAL DAMAGE TO ADJACENT TISSUE” by Johnson et al. andcommonly-assigned Application Ser. No. PCT/US01/11411 entitled“ELECTROSURGICAL INSTRUMENT WHICH IS DESIGNED TO REDUCE THE INCIDENCE OFFLASHOVER” by Johnson et al.

As mentioned above with respect to forceps 200, it is also contemplatedthat the forceps 500 (and/or the electrosurgical generator used inconnection with the forceps 500) may include an RF closed loop system,sensor or feedback mechanism (not shown) which automatically selects theappropriate amount of RF energy to effectively seal the particularelastin biomaterial 10′) and/or elastin biomaterial 10′ and tissuesubstrate) grasped between the jaw members 610 and 620. The sensor orfeedback mechanism may also measure the impedance across the elastinbiomaterial 10′ during sealing and provide an indicator (visual and/oraudible) that an effective seal has been created between the jaw members610 and 620.

Other embodiments of electrode assemblies are envisioned such as theelectrode assemblies described in commonly-owned PCT Patent ApplicationSer. No. PCT/US03/08146 entitled “BIPOLAR CONCENTRIC ELECTRODECONFIGURATION FOR SOFT TISSUE FUSION” which is incorporated in itsentirety by reference herein. FIGS. 5C-5E generally show variousconcentric electrode configurations described in the above-identifieddisclosure which include an array of electrode micro-sealing pads 800disposed across one or both jaw members 710 and 720. It is envisionedthat the array of micro-sealing pads 800 essentially spot weld areas oftissue between the micro-sealing pads 800 while allowing other tissueareas (i.e., tissue not contained between the micro-sealing pads)remains viable. As can be appreciated this promotes tissue healing.

More particularly, the electrical paths from the array of electrodemicro-sealing pads 800 are preferably mechanically and electricallyinterfaced with corresponding electrical connections disposed withinshafts 214 a and 214 b. For example and with respect to FIG. 5E, a firstelectrical path 726 having a first electrical potential is connected toeach ring electrode 820 of each electrode micro-sealing pad 800 and asecond electrical path 716 having a second electrical potential isconnected to each post electrode 830 of each electrode micro-sealing pad800. As can be appreciated, the jaw members 710 and 720 includenon-conductive contacting surfaces 784, 786, respectively, and an arrayof micro-sealing pads 800 disposed substantially along the entirelongitudinal length of each respective jaw member 710 and 720.Preferably, the non-conductive contacting surfaces 784, 786 are madefrom an insulative material such as ceramic, or, alternatively, thenon-conductive tissue contacting surfaces 784, 786 may be made from amaterial or a combination of materials having a high ComparativeTracking Index (CTI).

One or more stop members 150 a and 150 b may be positioned adjacent tothe non-conductive sealing surfaces 784, 786 or proximate pivot 750.Much like the embodiments described above, the stop members 150 a and150 b are designed to define a gap “G” (See FIG. 5B) between opposingjaw members 710 and 720 during the sealing process. It is envisionedthat the array of electrode micro-sealing pads 800 may also act as stopmembers for regulating the distance “G” between opposing jaw members 710and 720.

As best shown in FIG. 5C, the electrode micro-sealing pads 500 may bearranged in longitudinal, pair-like fashion along the jaw members 710and/or 720. The micro-sealing pads may be disposed on a single jawmember, e.g., 710, or on both jaw members 710 and 720. Alternatively,one jaw member, e.g., 710, may include a ring electrode 820 and theother jaw member 720 may include a post electrode 830. As such and asidentified in FIG. 5E, each post electrode 830 and the opposing ringelectrode 820 together define one electrode micro-sealing pad 800.

Preferably, the post electrode 830 is concentrically centered oppositethe ring electrode 820 such that when the jaw members 710 and 720 areclosed about the elastin biomaterial 10′ (and/or elastin biomaterial 10′and tissue substrate 900), RF energy flows from the ring electrode 820,through tissue and to the post electrode 830. Insulating materials 814and 824 isolate the electrodes 820 and 830 and prevent stray currenttracking to surrounding tissue areas.

A controller (not shown) may be electrically interposed between thegenerator 350 and the electrodes 820, 830 to regulate the RF energysupplied thereto depending upon certain electrical parameters, i.e.,current impedance, temperature, voltage, etc. For example, theinstrument or the controller may include one or more smart sensors (notshown) which communicate with the electrosurgical generator 350 (orsmart circuit, computer, feedback loop, etc.) to automatically regulatethe electrical intensity (waveform, current, voltage, etc.) to enhancethe micro-sealing process. The sensor may measure or monitor one or moreof the following parameters: temperature, impedance at the micro-seal,change in impedance over time and/or changes in the power or currentapplied over time. An audible or visual feedback monitor (not shown) maybe employed to convey information to the surgeon regarding the overallmicro-seal quality or the completion of an effective micro-seal.Examples of a various control circuits, generators and algorithms whichmay be utilized are disclosed in commonly-owned U.S. Pat. No. 6,228,080and U.S. application Ser. No. 10/073,761 entitled “VESSEL SEALINGSYSTEM” the entire contents of both of which are hereby incorporated byreference herein.

During sealing, an intermittent pattern of individual micro-seals iscreated along and across the elastin biomaterial 10′ and tissuesubstrate 900. The arrangement of the micro-sealing pads 800 across thejaws 710 and 720 only seals the elastin biomaterial 10′ and tissuesubstrate 900 which is between each micro-sealing pad 800. The adjacentelastin biomaterial 10′ (and/or tissue substrate 900) remains viablewhich, as can be appreciated, allows blood and nutrients to flow throughthe sealing site and between the individual micro-seals to promotehealing and reduce the chances of tissue necrosis. By selectivelyregulating the closure pressure, gap distance “G”, and electrosurgicalintensity, effective and consistent micro-seals may be created for manydifferent types of biomaterials. For example, it is also envisioned thatthe pattern and/or density of the micro-sealing pads 800 may beconfigured along a jaw member 710 and/or 720 to seal different types orthicknesses of elastin biomaterial 10′.

Experimental results suggest that the magnitude of pressure exerted bythe micro-sealing pads 800 is important in assuring a proper surgicaloutcome, maintaining tissue viability. Pressures within a working rangeof about 3 kg/cm² to about 16 kg/cm² and, preferably, within a workingrange of about 4.5 kg/cm² to about 8.5 kg/cm² have been shown to beeffective for micro-sealing. The micro-sealing pads 800 may be arrangedin many different configurations across or along the jaw members 710 and720 depending upon a particular purpose.

FIG. 5A shows the two opposing jaw members 610 and 620 of the openforceps 500 poised for grasping an elastin patch 10′ and tissue 900 (orother biomaterial or other elastin 10′) prior to activation and sealing.More particularly and as described in detail above, once the elastinbiomaterial 10′ is prepared and formed into the desired shape, thicknessand consistency it can be fused to tissue 900 (or other biomaterial)utilizing one or more of the above described vessel sealing devices,namely, endoscopic forceps 200, open forceps 500 or 700. The uniquecombination of controlled RF energy, pressure (within a specifiedpressure range) and specific gap distances between opposing tissuecontacting surfaces melt the elastin biomaterial 10′ and tissue 900 intoa single mass. FIG. 5B shows the open forceps 500 in a substantiallyclosed position about a patch of elastin 10′ and tissue 900 prior tosealing. As can be appreciated, the opposing jaw members 610 and 620maintain a specific gap distance “G” necessary for effective sealing ofthe elastin patch 10′ and the tissue 900.

Utilizing the inherent electrical, thermal and physical properties ofthe elastin biomaterial 10′ and tissue 900 coupled with the uniqueattributes associated with the above-described vessel sealinginstruments 200, 500 and 700 (i.e., pressure, gap, RF energy control,electrode design, etc.), a fluid tight, hemostatic and structured fuseis created. It is envisioned that the resulting fuse between the elastin10′ and the tissue 900 is fairy homogeneously with only slightdemarcation between the two layers (See FIG. 2B). Moreover and unlikelaser welding, energy absorbing dyes, e.g., indocyanine green, are notnecessary to control or regulate the fusing process.

It is envisioned that the elastin biomaterial 10′ may be secured orfused to tissue substrates, soft tissue (lung, intestine, bowel, bloodvessels, muscles, skin, etc.) or other biomaterials as a means fortissue healing, reconstruction, repair and replacement. As mentionedabove, sheets or patches of elastin biomaterial 10′ may be selectivelyvaried in size, thickness and shape and/or may be formed into molds(tubular or otherwise) and scaffolding depending upon the intendedpurpose for the elastin biomaterial 10′. As a result, the elastinbiomaterial 10′ may be used to repair portions of diseased or damagedvascular tissue, nonvascular tissue (e.g., esophagus, paracardium, lung,etc.) or as a skin layer replacement for use in burn or woundtreatments. In addition, the elastin biomaterial 10′ may also be used inorgan reconstruction, e.g., molded in a pouch-like configuration forbladder reconstruction or shaped for esophageal replacement.

FIGS. 6A-6B and 7A-7B show envisioned methods of using the elastin patch10′ for creating an end-to-end anastomosis of two vessel segments 900and 900′. More particularly, FIGS. 6A and 6B show a schematicrepresentation of a general circular anastomosis vessel sealinginstrument 1000 having opposing jaw members 1010 a and 1010 b. The twovessel segments 900 and 900′ are preferably everted to expose the vesselintima 910 and 910′, respectively. The vessel intimas 910 and 910′ arejuxtaposed and two rings of elastin biomaterial 10′ are positioned abouteach vessel segment 900 and 900′ on an external side thereof. Theopposing jaw members 1010 a and 1010 b are then positioned on eitherside of the two vessel segments 900 and 900′ with the elastinbiomaterial 10′ disposed therebetween. The jaw members 1010 a and 1010 bare then compressed about the elastin 10′ and the tissue 900 and 900′(e.g., with a force “F” within the preferred working range of about 3kg/cm² to about 16 kg/cm² or, preferably, about 4.5 kg/cm² to about 8.5kg/cm²) to form a seal.

It is envisioned that the two elastin 10′ rings and the two vessels 900and 900′ reforms into a single fused mass and/or that the elastinmaterial 10′ alone reform into a fused mass to hold the anastomosis. Ineither instance, the resulting anastomosis remains intact.

FIGS. 7A-7B show an alternate method of performing an end-to-endanastomosis wherein the elastin biomaterial 10′ is positioned betweenthe intimal, abutting surfaces 910 and 910′ of the two vessels 900 and900′, respectively. Much in the same fashion as described above, the twojaw members 1010 a and 1010 b are positioned about the vessels 900 and900′ and compressed to form a seal. Again, the elastin biomaterial 10′and the two vessels 900 and 900′ reform into a fused mass.

Alternatively, the biomaterial 10′ may be fused directly with a vessel900. More particularly, FIGS. 9A and 9B show a schematic representationof a circular anastomosis similar to the above figures wherein a vesselsegment 900 and segment of biomaterial 10′ are everted to expose theirrespective intimas 910 and 10″. The vessel intimas 910 and 10″ arejuxtaposed and on their external sides and the opposing jaw members 1010a and 1010 b are then positioned on either side of the two vesselsegments 900 and 10′. The jaw members 1010 a and 1010 b are thencompressed about the elastin 10′ and the tissue 900 to form a seal.

Alternatively, the elastin biomaterial 10′ may be used as reinforcementto conventional circular stapling (See FIG. 8). For example, aconventional circular stapling device 1100 may be configured with astapler support 1110 a, an anvil 1110 b, conductive sealing plates 1112a and 1112 b, stop members (not shown) and an appropriateforce-actuating mechanism (not shown) necessary to seal tissue (asdescribed in detail above). The circular stapler 1100 is then positionedin a normal, conventional fashion about the two vessels segments 900 and900′ with the elastin biomaterial 10′ disposed about the vessel segments900, 900′ or between the vessel segments 900, 900′ as described above.Prior to activating the stapler 1100, the vessel segments 900, 900′ andthe elastin biomaterial 10′ are fused in accordance with vessel sealingparameters described herein. Once stapled, it is envisioned that theelastin biomaterial 10′ will reinforce the stapled anastomosis.

It is also envisioned that a segment of biomaterial 10′ and tissue 900may be directly fused together prior to stapling. For example and asbest shown in FIG. 10, a segment of biomaterial 10′ and a vessel 900 mayboth be everted to expose the vessel intimas 10″ and 910, respectively.A circular stapler 1100 is then positioned about the two segments 900and 10′ as described above. Prior to activating the stapler 1100, thevessel segment 900 and the biomaterial segment 10′ are directly fused inaccordance with vessel sealing parameters described herein.

From the foregoing and with reference to the various figure drawings,those skilled in the art will appreciate that certain modifications canalso be made to the present disclosure without departing from the scopeof the present disclosure. For example, although only an elastinbiomaterial 10′ has been described herein, it is contemplated that otherbiomaterials may also be sealed to heal, repair, replace and/orreconstruct tissue, e.g., collagen-based materials, elastin-basedmaterials and fibrin-based materials. Moreover, the biomaterials may benatural, synthetic and/or engineered biomaterials depending upon aparticular purpose. The biomaterials may be sealed or fused to tissuesubstrates, soft tissue (lung, intestine, bowel, blood vessels, muscles,skin, etc.) or other biomaterials utilizing the afore described vesselsealing instruments (or other vessel sealing instruments). As can beappreciated, each particular type of biomaterial may have differentsealing parameters and optimum gap and pressure ranges. For example, itis contemplated that Cook Surgical Surgisis Gold porcine collagenbiomaterial which is commonly used for hernia repair graft may be fusedwith fresh porcine peritoneum or fresh porcine fascia or fused withanother graft of Surgical Surgisis Gold material to produce a desiredsurgical result. It is envisioned that Surgical Surgisis Gold may befused with itself, other biomaterials or other types of human tissues tocreate various types of afore described grafts, fusions, anastomosesand/or tissue seals. Moreover and as can be appreciated, sheets orpatches of Surgical Surgisis Gold may be selectively varied in size,thickness and shape and/or may be formed into molds and scaffoldingdepending upon the intended purpose for the biomaterial.

Moreover, the RF energy may need to be regulated or controlled (feedbackloop, algorithm, closed loop system, etc.) depending upon the type ofbiomaterial. It is envisioned that various sensors may be employed toclosely monitor various tissue parameters (impedance, temperature,moisture, etc.) to optimize the sealing process for each type ofbiomaterial.

It is also envisioned that the forceps 200, 500 and 700 may be designedsuch that it is fully or partially disposable depending upon aparticular purpose or to achieve a particular result. For example, jawassembly 400 may be selectively and releasably engageable with thedistal end 214 of the shaft 212 and/or the proximal end 216 of shaft 212may be selectively and releasably engageable with the housing 220 andthe handle assembly 230. In either of these two instances, the forceps200 would be considered “partially disposable” or “reposable”, i.e., anew or different jaw assembly 400 (or jaw assembly 400 and shaft 212)selectively replaces the old jaw assembly 400 as needed.

It is also envisioned that the jaws members 410 and 420 may closed in atip-based or heel-based fashion. Alternatively, the jaw members 410 and420 may close in a parallel or independently floating (with respect toparallel) fashion. It is also contemplated that optimizing hydrationlevels of a biomaterial prior to sealing may be desired, e.g., pressingthe biomaterial with gauze. This may be included as an additional stepin the sealing process.

As mentioned above, for certain applications, it may be desirable to usethe biomaterial with a supporting material having strong mechanicalproperties, e.g., polymers, such as woven polyethylene terepthalate(Dacron), teflon, polyolefin copolymer, polyurethane polyvinyl alcohol,polyacrylic or other polymers.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular embodiments. Those skilled in the artwill envision other modifications within the scope and spirit of theclaims appended hereto.

1. A method of fusing biomaterials, comprising the steps of: providing acircular stapling instrument having a support member configured tosupport an array of staples and an opposing anvil, the support membermovable relative to the anvil to compress tissue therebetween, each ofthe support member and the anvil having electrically conductive sealingsurfaces; providing a non-collagen biomaterial; everting an end of asegment of non-collagen biomaterial; positioning the evened end of thenon-collagen biomaterial in abutting relation to an everted end of atleast one other tissue such that the respective intimae of the evertednon-collagen biomaterial and the at least one other tissue oppose oneanother, the at least one other tissue selected from the groupconsisting of collagen biomaterial, non-collagen biomaterial and elastinbiomaterials; compressing the non-collagen biomaterial and the at leastone other tissue between the support member and the anvil; energizingthe support member and the anvil with radiofrequency energy toeffectively fuse the non-collagen biomaterial and the at least one othertissue such that the at least one other tissue and the non-collagenbiomaterial reform into a single, fused mass; and actuating the circularstapling instrument to fire the staples through the non-collagenbiomaterial and the at least one other tissue and against the anvil. 2.A method of fusing biomaterials according to claim 1 wherein compressingthe non-collagen biomaterial and the at least one other tissue betweenthe support member and the anvil comprises compressing under a workingpressure within the range of about 3 kg/cm² to about 16 kg/cm².
 3. Amethod of fusing biomaterials according to claim 1 wherein at least oneof the support member and the anvil include at least one the stop memberthat regulates the distance between opposing jaw members within therange of about 0.004 inches to about 0.010 inches.